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Three-Year Outcomes After Bifurcation Stenting With Zotarolimus-Eluting Stents: Final Results From the RESOLUTE ONYX Postapproval Study.


ABSTRACT:

Background

Bifurcation represents a challenging lesion subset for percutaneous coronary intervention.

Methods

In this prospective study of the Resolute Onyx zotarolimus-eluting stent (ZES), patients with a single bifurcation target lesion who underwent planned treatment using a provisional stenting technique were enrolled at 25 centers in the United States and Europe. The primary end point was target-vessel failure (TVF) at 1 year, and follow-up was performed through 3 years.

Results

A total of 205 patients were enrolled. Mean age was 66.6 ± 10.7 years, 21.5% of patients were female, and diabetes mellitus was present in 30.2%. A provisional approach with a single stent was performed in 96.6% of patients. The rate of TVF at 1 year was 7.4%, fulfilling the prespecified performance criterion (upper 1-sided 95% CI of 11.1%, compared with the performance goal of 24.5%). At 3-year follow-up, the rate of TVF was 12.1%, the rate of clinically driven target-lesion revascularization was 6.0%, and there were no episodes of stent thrombosis related to the target lesion. Event rates were consistent among the cohort of patients with angiographic core laboratory-confirmed bifurcation lesions.

Conclusions

In this prospective, multicenter study, bifurcation lesion treatment with Resolute Onyx ZES using a planned provisional stent approach was associated with favorable clinical outcomes through 3 years. These results support the longer-term safety and effectiveness of Resolute Onyx ZES to treat bifurcation lesions that are amenable to a planned provisional stenting technique.

SUBMITTER: Price MJ 

PROVIDER: S-EPMC11308709 | biostudies-literature | 2023 Nov-Dec

REPOSITORIES: biostudies-literature

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Three-Year Outcomes After Bifurcation Stenting With Zotarolimus-Eluting Stents: Final Results From the RESOLUTE ONYX Postapproval Study.

Price Matthew J MJ   Boutis Loukas L   Kirtane Ajay J AJ   Chetcuti Stanley S   Poliačiková Petra P   Dens Joseph J   Attubato Michael M   Wang Yale Y   Hu Patrick P   Spriggs Douglas D   Krasnow Joshua J   Chatzizisis Yiannis Y   Aminian Adel A   Caputo Ronald R   Shah Alpesh A   Dauler Michelle M   Ibrahim Sherif S   Lung Te-Hsin TH   Mehran Roxana R  

Journal of the Society for Cardiovascular Angiography & Interventions 20230805 6Part A


<h4>Background</h4>Bifurcation represents a challenging lesion subset for percutaneous coronary intervention.<h4>Methods</h4>In this prospective study of the Resolute Onyx zotarolimus-eluting stent (ZES), patients with a single bifurcation target lesion who underwent planned treatment using a provisional stenting technique were enrolled at 25 centers in the United States and Europe. The primary end point was target-vessel failure (TVF) at 1 year, and follow-up was performed through 3 years.<h4>R  ...[more]

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